Rahul Aggarwal, MD, highlights phase 3 PRESTO findings in BCR prostate cancer

The phase 3 PRESTO trial (NCT03009981) assessed combined androgen signaling blockade for a finite treatment period of 52 weeks in patients with high-risk biochemically relapsed prostate cancer.

Final results from the study were recently presented at the the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.¹ In an interview with Urology Times®, presenting author Rahul Aggarwal, MD, outlined the key findings from the trial. Aggarwal is a genitourinary medical oncologist at the University of California, San Francisco.

In total, the study enrolled 503 patients who were randomly assigned to receive ADT alone (arm A; n = 166), ADT plus apalutamide (arm B; n = 168), or ADT plus apalutamide plus abiraterone acetate and prednisone (arm C; n = 169). Previous data from the trial, published in the Journal of Clinical Oncology, showed that both experimental arms extended prostate-specific antigen progression-free survival relative to the control arm of ADT alone.²

The data presented at ESMO included findings on the key secondary objectives of metastasis-free survival (MFS) and time to castration resistance. The median follow-up time was 61 months.

Overall, the hazard ratios for MFS vs the control arm were 0.80 (95% CI, 0.56 to 1.13) in the ADT plus apalutamide arm and 0.92 (95% CI, 0.56 to 1.13) in the triplet arm.

The authors also reported, “The difference in [restricted mean survival time] over the first 48 months for MFS between ADT + APA vs ADT was 2.92 months (95% CI, 0.45 to 5.39) and for ADT + APA + AAP vs ADT was 2.41 months (95% CI, -0.20 to 4.62).” ADT plus apalutamide and the triplet regimen also both showed improvements vs ADT monotherapy in the time to castration-resistant prostate cancer (HR, 0.58; 95% CI, 0.36 to 0.95; P = .0283) and the time to subsequent therapy (HR, 0.75; 95% CI, 0.56 to 1.00; P = .0075).

Aggarwal explained, “The overall conclusion of this study is ADT plus apalutamide is already part of consensus NCCN guidelines as a treatment option for high-risk, biochemically relapsed patients, and these longer term follow-up data certainly still support that recommendation.”

REFERENCE

1. Aggarwal R, Hillman D, Xiao H, et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract LBA88. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA88.html.pdf

2. Aggarwal R, Heller G, Hillman DW, et al. PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19). J Clin Oncol. 2024;42(10):1114-1123. doi:10.1200/JCO.23.01157